SAN DIEGO, Dec. 15 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has initiated and dosed the initial cohorts of volunteer subjects in a clinical trial of subcutaneous (SC) hydration (hypodermoclysis) with Hylenex(TM). Hylenex is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase (rHuPH20). Subcutaneous hydration is the introduction of fluids under the skin, eliminating the need for inserting a catheter into the vein, to replace inadequate intake or excessive loss of water and electrolytes during illness or operation. Hylenex is a recombinant human hyaluronidase approved for use as a spreading agent to accelerate the delivery of fluids and drugs, such as local anesthesics and other co-injected drugs, contrast agents, and for subcutaneous (SC) fluid replacement. Halozyme received FDA approval for Hylenex on December 2, 2005.
The INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, is designed to determine the subcutaneous infusion flow rate of lactated Ringer’s solution with and without Hylenex, assess the subcutaneous infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. Lactated Ringer’s solution is a widely used fluid for intravenous rehydration. The double-blind, randomized, placebo-controlled, dose-comparison study will enroll up to 70 subjects.
“Establishing a favorable risk-benefit ratio could lead to the widespread adoption of rapid SC hydration as the parenteral infusion route of choice for clinically dehydrated patients in many clinical scenarios,” said Jay Thomas, MD, PhD, Clinical Medical Director of San Diego Hospice & Palliative Care. “Because SC hydration requires less skill to implement and can be delivered in a wider variety of patient care settings, it may also have a favorable impact on the cost of healthcare. For example, rather than transferring a dehydrated patient to an emergency room, a hospital, or a skilled nursing facility, SC hydration could be given in the home or in a doctor’s office.”
About Hylenex
Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hylenex recombinant is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. The contraindications and warnings regarding the use of Hylenex should be recognized and adhered to
prior to prescription or administration. For full prescribing information, visit www.halozyme.com.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company’s portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme’s recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company’s products under development, product development plans, regulatory strategy, regulatory filing dates and clinical trials) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company’s reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.
Halozyme Contact Investor Relations Contacts David A. Ramsay Don Markley / Zachary Bryant Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.comdmarkley@lhai.com Media Contacts Kathy Sweeney / Joleen Schultz Mentus (858) 455-5500, x230/x215 kwitz@mentus.comjschultz@mentus.com
Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of HalozymeTherapeutics, Inc., +1-858-794-8889, dramsay@halozyme.com; or Investors,Don Markley, dmarkley@lhai.com, or Zachary Bryant, both ofLippert/Heilshorn & Associates, +1-310-691-7100, for Halozyme Therapeutics,Inc.; or Media, Kathy Sweeney, ext. 230, kwitz@mentus.com, or JoleenSchultz, ext. 215, jschultz@mentus.com, both of Mentus, +1-858-455-5500,for Halozyme Therapeutics, Inc.
Web site: http://www.halozyme.com//
